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TRAUMA HELP: Healing and Analgesia With Propranolol

Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01007084
Acronym
TRAUMA_HELP
Enrollment
0
Registered
2009-11-03
Start date
2009-10-31
Completion date
2010-07-31
Last updated
2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Keywords

pain, trauma, propranolol

Brief summary

The purpose of this study is to determine whether propranolol can decrease pain symptoms in a common subset of patients admitted to a trauma center after injury.

Detailed description

The main purpose of this pilot study is to investigate Propranolol's utility in the trauma population. Specifically, to see if it reduces pain scores post-injury.

Interventions

DRUGPropranolol

40 mg

120 mg twice per day

sugar pill

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* at least one fracture * ages 18-60 yrs * pain score \>= 4 * speak and read English

Exclusion criteria

* gunshot, stab wound, or assault * paraplegia/quadriplegia * pregnancy * psychotic, suicidal, or homicidal * hepatic, kidney failure * clinically unstable or intubated at time of recruitment * hyperthyroidism * propranolol use within the last 6 months * significant bradycardia * cancer (except basal cell) * peripheral vascular disease * heart block \> 1 degree * breastfeeding * congestive heart failure

Design outcomes

Primary

MeasureTime frame
Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.Study days 1, 3, 5, 7, 10, 13, 17, and 19

Secondary

MeasureTime frame
Sleep qualityMOS Sleep Scale
Anxiety symptoms7 days, 6 weeks, 3 months, 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026